HIV InfectionsPhase 3NCT00323544
SWEET: Once Daily Truvada Versus Twice Daily Combivir for the Treatment of HIV Infection
A Phase 3 study testing zidovudine and lamivudine (Combivir®) and emtricitabine and tenofovir DF in people with HIV Infections, run by Gilead Sciences at 1 site in United Kingdom.
Trial summary
This study will investigate whether the simplified regimen of a once daily fixed dose combination of Truvada (emtricitabine and tenofovir disoproxil fumarate [DF]) will be associated with a reduced rate of adverse events, seen with long term use of antiretrovirals, as well as improved adherence compared to a twice… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- zidovudine and lamivudine (Combivir®) and emtricitabine and tenofovir DF
- How many people
- 220 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2004to Oct 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either sex aged > 18 years.
- HIV positive.
- Stable antiretroviral therapy consisting of efavirenz (EFV) given with Combivir® or zidovudine (AZT) + lamivudine (3TC) for at least 6 months.
- Patients with viral loads < 50 copies/ml on last 2 consecutive tests and < 400 copies/ml for > 3 months.
- Patients requiring a lipid lowering agent must be established on a stable dose/frequency for at least 12 weeks prior to Baseline and be expected to continue on stable dose/frequency for the duration of the study.
- Negative serum pregnancy test (females of childbearing potential only).
- Willingness to use effective contraception (such as barrier or coil methods) by both males and females while on study treatment and for 30 days following study drug completion.
- The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
Who cannot join
- Pregnant or lactating female.
- History of AZT monotherapy.
- Use of anabolic steroids, with the exception of testosterone for documented hypogonadism, within 90 days prior to the Baseline visit.
- Documented parvovirus infection.
- Use of erythropoietin within the last six weeks.
- Patients who have had a blood transfusion in the last six weeks.
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- Karnofsky score < 50.
- Prior history of significant renal disease.
- Prior history of osteopenia/osteoporosis.
- Creatinine clearance < 60mL/min.
- AST/ALT > 5 x upper limits of normal (ULN).
- Previous adefovir dipivoxil or cidofovir therapy.
- Known history of resistance (including primary resistance) to any of the study medications - tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), AZT, 3TC, or EFV.
- Patients receiving ongoing therapy with any of the following (administration of any of the following medications must be discontinued at least 30 days prior to the Baseline visit and for the duration of the study period):
- Nephrotoxic agents
- Probenecid
- Systemic chemotherapeutic agents (i.e. cancer treatment medications)
- Systemic corticosteroids
- Interleukin 2 (IL 2)
- Drugs that interact with efavirenz
- Dihydroergotamine
- Ergotamine
- Midazolam
- Triazolam
- Cisapride
- Rifampin
- Ergonovine
- Methylergonovine
- Patients with known hypersensitivity to any of the study medications or excipients.
- Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic therapy within 15 days prior to Screening.
- Patients who are currently taking part in any other clinical trial or have taken part in a clinical trial of a new chemical entity within 1 month prior to Screening.
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements.
- Patients with cancer (except basal cell carcinoma).
- Co-infection with hepatitis B virus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Open Label, Randomised, Parallel Group Study to Compare the Effect on Prevention and Resolution of Treatment Related Adverse Events of a Simplified, Once Daily Regimen of a Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus Twice Daily co-Formulated Zidovudine and Lamivudine (Combivir®) or Zidovudine and Lamivudine, in Virologically Suppressed, HIV Infected Patients Taking Efavirenz
This study will investigate whether the simplified regimen of a once daily fixed dose combination of Truvada (emtricitabine and tenofovir disoproxil fumarate [DF]) will be associated with a reduced rate of adverse events, seen with long term use of antiretrovirals, as well as improved adherence compared to a twice daily fixed dose combination of Combivir.
Read the detailed description
The success of HAART is largely dependant on an individual's ability to adhere strictly to an antiretroviral regimen. Regimen characteristics that affect adherence include dosing frequency and pill burden. Several studies have shown improved adherence with lower pill burden and a meta-analysis of the virological outcome in relation to pill burden has shown a significant correlation between lower pill burden and better virological outcome. A systematic review of studies across a range of medical specialties demonstrated that once daily therapy improves adherence relative to more frequent dosing although statistical significance was not demonstrated relative to twice daily regimens.
- Conditions
- HIV Infections
- Being tested
- zidovudine and lamivudine (Combivir®), emtricitabine and tenofovir DF
- Keywords
- HIV 1, HIV 1 infection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zidovudine and lamivudine (Combivir®)Drug
emtricitabine and tenofovir DFDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint for the study is a change from baseline in absolute haemoglobin at Week 24.
Secondary outcomes (12)
The secondary endpoints in this study include: Change from baseline in absolute haemoglobin at Week 48
Lipids profile: change from baseline in total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), TC/HDL, and triglyceride (TG)
Quality of life (QoL)
Measures of treatment adherence (Medication Adherence Self-Report Survey [MASRI] questionnaire)
Measures of regimen intrusiveness (HIS and Brief Medication Questionnaire [BMQ])
Changes in markers of body composition from dual energy x-ray absorptiometry (DEXA) scans (a sub-study)
HIV RNA: proportion of patients with HIV ribonucleic acid (RNA) < 400 copies/mL; proportion of patients with HIV RNA < 50 copies/mL and change from baseline in log10 copies/mL at Weeks 24 and 48
CD4: change from baseline in CD4 counts
Treatment adherence and acceptability
Use of lipid lowering drugs (number of patients and duration of use)
Adverse events (AEs): AEs will be coded and the coded terms will be used to summarize the count of patients with any event, intensity of each event (highest intensity will be used if an event is reported more than once by a patient) and relationship to:
Other lab tests: results at baseline and changes from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startOct 2004
- Primary completionJun 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Claudio Avila, MD, Study director, Gilead Sciences, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323544
- Sponsor's protocol ID
- GS-MC-164-0111
- Status last verified
- Jun 2008
- First submitted
- 5 May 2006
- Last updated
- 4 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Fisher M, Moyle GJ, Shahmanesh M, Orkin C, Kingston M, Wilkins E, Ewan J, Liu H, Ebrahimi R, Reilly G; SWEET (Simplification With Easier Emtricitabine Tenofovir) group UK. A randomized comparative trial of continued zidovudine/lamivudine or replacement with tenofovir disoproxil fumarate/emtricitabine in efavirenz-treated HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2009 Aug 15;51(5):562-8. doi: 10.1097/QAI.0b013e3181ae2eb9.
PubMed 19561519
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open Label, Randomised, Parallel Group Study to Compare the Effect on Prevention and Resolution of Treatment Related Adverse Events of a Simplified, Once Daily Regimen of a Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus Twice Daily co-Formulated Zidovudine and Lamivudine (Combivir®) or Zidovudine and Lamivudine, in Virologically Suppressed, HIV Infected Patients Taking Efavirenz
- ClinicalTrials.gov ID
- NCT00323544
- Acronym / sponsor ID
- GS-MC-164-0111
- Conditions
- HIV Infections
- Keywords
- HIV 1, HIV 1 infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 9 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate whether the simplified regimen of a once daily fixed dose combination of Truvada (emtricitabine and tenofovir disoproxil fumarate [DF]) will be associated with a reduced rate of adverse events, seen with long term use of antiretrovirals, as well as improved adherence compared to a twice daily fixed dose combination of Combivir.
Detailed description
The success of HAART is largely dependant on an individual's ability to adhere strictly to an antiretroviral regimen. Regimen characteristics that affect adherence include dosing frequency and pill burden. Several studies have shown improved adherence with lower pill burden and a meta-analysis of the virological outcome in relation to pill burden has shown a significant correlation between lower pill burden and better virological outcome. A systematic review of studies across a range of medical specialties demonstrated that once daily therapy improves adherence relative to more frequent dosing although statistical significance was not demonstrated relative to twice daily regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients of either sex aged > 18 years.
- HIV positive.
- Stable antiretroviral therapy consisting of efavirenz (EFV) given with Combivir® or zidovudine (AZT) + lamivudine (3TC) for at least 6 months.
- Patients with viral loads < 50 copies/ml on last 2 consecutive tests and < 400 copies/ml for > 3 months.
- Patients requiring a lipid lowering agent must be established on a stable dose/frequency for at least 12 weeks prior to Baseline and be expected to continue on stable dose/frequency for the duration of the study.
Key exclusion criteria (34 listed)
- Pregnant or lactating female.
- History of AZT monotherapy.
- Use of anabolic steroids, with the exception of testosterone for documented hypogonadism, within 90 days prior to the Baseline visit.
- Documented parvovirus infection.
- Use of erythropoietin within the last six weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zidovudine and lamivudine (Combivir®) | Drug | – |
| emtricitabine and tenofovir DF | Drug | – |
Primary outcome
The primary endpoint for the study is a change from baseline in absolute haemoglobin at Week 24.
12 secondary outcomes
The secondary endpoints in this study include: Change from baseline in absolute haemoglobin at Week 48
Lipids profile: change from baseline in total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), TC/HDL, and triglyceride (TG)
Quality of life (QoL)
Measures of treatment adherence (Medication Adherence Self-Report Survey [MASRI] questionnaire)
Measures of regimen intrusiveness (HIS and Brief Medication Questionnaire [BMQ])
Changes in markers of body composition from dual energy x-ray absorptiometry (DEXA) scans (a sub-study)
HIV RNA: proportion of patients with HIV ribonucleic acid (RNA) < 400 copies/mL; proportion of patients with HIV RNA < 50 copies/mL and change from baseline in log10 copies/mL at Weeks 24 and 48
CD4: change from baseline in CD4 counts
Treatment adherence and acceptability
Use of lipid lowering drugs (number of patients and duration of use)
Adverse events (AEs): AEs will be coded and the coded terms will be used to summarize the count of patients with any event, intensity of each event (highest intensity will be used if an event is reported more than once by a patient) and relationship to:
Other lab tests: results at baseline and changes from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2008.
- Derived from this study: PubMed 19561519Fisher M, Moyle GJ, Shahmanesh M, Orkin C, Kingston M, Wilkins E, Ewan J, Liu H, Ebrahimi R, Reilly G; SWEET (Simplification With Easier Emtricitabine Tenofovir) group UK. A randomized comparative trial of continued zidovudine/lamivudine or replacement with tenofovir disoproxil fumarate/emtricitabine in efavirenz-treated HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2009 Aug 15;51(5):562-8. doi: 10.1097/QAI.0b013e3181ae2eb9.
- Study ResultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Avila, MD study director
Gilead Sciences, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing zidovudine and lamivudine (Combivir®) and emtricitabine and tenofovir DF in people with HIV Infections, run by Gilead Sciences at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint for the study is a change from baseline in absolute haemoglobin at Week 24.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00323544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2008.